Chimerix Signs Worldwide License Agreement with Merck for CMX157, A Novel Candi

StephenW

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Chimerix Signs Worldwide License Agreement with Merck for CMX157, A Novel Candidate for the Treatment of HIV    99.91 KB  [url=] Print[/url]
RESEARCH TRIANGLE PARK, NC – July 24, 2012 – Chimerix, Inc. today announced the execution of a license agreement granting Merck, known as MSD outside the United States and Canada, exclusive worldwide rights to CMX157, Chimerix's novel lipid acyclic nucleoside phosphonate currently being evaluated to treat HIV infection.
Under the terms of the agreement, Merck receives an exclusive worldwide license and will be responsible for development and commercialization of CMX157, an investigational oral nucleoside reverse transcriptase inhibitor (NRTI).  Chimerix will receive a $17.5 million upfront payment and will be eligible to receive up to $151 million in milestones, as well as royalties on future sales.
"This agreement is a significant milestone in Chimerix's mission of developing best-in-class therapies for major unmet medical needs based on our lipid technology platform," said Kenneth I. Moch, President and CEO of Chimerix.  "Merck is the ideal collaborator to develop this drug and help us to maximize the potential of CMX157, given its commitment to its HIV franchise.  The value created through the licensure of CMX157 will help us continue to advance our lead compound, CMX001, through its critical Phase 3 trial, for which we currently plan to begin enrolling patients early next year."
"Merck is committed to bringing forward new treatment options for patients with HIV/AIDs," said Daria Hazuda, Vice President and Worldwide Discovery Head for Infectious Diseases, Merck Research Laboratories.  "We look forward to working closely with Chimerix to advance development of this NRTI candidate."
About CMX157
CMX157 is a novel lipid acyclic nucleoside phosphonate that delivers high intracellular concentrations of the active antiviral agent tenofovir diphosphate.  CMX157 is more than 200-fold more potent in vitro versus tenofovir against all major HIV subtypes resistant to current therapies, which may allow activity against tenofovir-resistant viruses (e.g., K65R), and against HBV.  CMX157's novel structure results in decreased circulating levels of tenofovir, lowering systemic exposure and thereby reducing the potential for renal side effects.  CMX157 has completed a Phase 1 clinical trial in healthy volunteers, demonstrating a favorable safety, tolerability and drug distribution profile.
About Chimerix
Led by an experienced antiviral drug development team, Chimerix is developing novel oral antiviral therapeutics with the potential to improve quality of life for patients in multiple settings, including transplant, oncology, acute care and global health.  The company's proprietary lipid technology has given rise to two clinical stage compounds, CMX001 and CMX157, which have demonstrated the potential for enhanced activity, bioavailability and safety compared to currently approved drugs.
Chimerix's lead compound, CMX001, is a broad spectrum lipid acyclic nucleoside phosphonate that inhibits double-stranded DNA (dsDNA) viruses including cytomegalovirus (CMV), adenovirus, BK virus, herpes simplex virus and variola (smallpox).  CMX001 has completed Phase 2 clinical development for the prophylaxis of CMV and is in Phase 2 development for the preemption and treatment of adenovirus infection in hematopoietic stem cell transplant (HSCT) recipients.  To date, more than 750 patients have been dosed with CMX001 in controlled clinical trials and open-label treatment protocols.  Antiviral activity from completed and ongoing studies, coupled with the lack of myelotoxicity and nephrotoxicity that are associated with currently available therapies, indicate that CMX001 has the potential to improve outcomes for stem cell and solid organ transplant recipients.  Chimerix has completed an End of Phase 2 meeting with the FDA for CMX001 and is preparing to initiate Phase 3 clinical development of CMX001 for the prophylaxis of CMV in HSCT recipients.

StephenW

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chimerix签署CMX157与默克公司的全球许可协议，治疗艾滋病毒的一个新的候选
   
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北卡罗来纳州研究三角公园 - 七月24，2012  -  Chimerix，公司今天宣布，给予默克公司，美国和加拿大以外的MSD称为许可协议的执行，CMX157的全球独家权利，Chimerix的新型脂质无环核苷膦目前正在评估治疗艾滋病毒感染。

根据协议条款，默克公司收到的全球独家授权，将负责为CMX1​​57，开发和商业化的口服核苷类逆转录酶抑制剂（NRTI的）。 chimerix将收到1750万美元的预付款，将有资格获得高达151亿美元的里程碑，以及对未来销售的版税。

“这项协议是一个在Chimerix制定最佳的治疗主要满足医疗需求，根据我们的脂技术平台的使命的重要里程碑，一Moch，总裁兼首席执行官的Chimerix说：”肯尼思。 “默克公司是理想的合作者开发这种药物，并帮助我们最大限度地对CMX157的潜力，给予其艾滋病毒的专营权的承诺。通过CMX157执照，所创造的价值，将有助于我们继续推进我们的先导化合物，CMX001通过其关键的第三阶段试验，而我们目前计划在明年年初开始招收患者。“

“默克公司致力于与艾滋病毒/艾滋病患者提出的新的治疗方案，说：”达里亚Hazuda，副总裁和全球传染病，默克研究实验室发现头。 “我们期待着工作与Chimerix的密切合作，以推动发展这NRTI的候选人。”

关于CMX157

CMX157是一种新型的脂质，提供积极的抗病毒药物替诺福韦二磷酸的细胞内浓度高的无环核苷膦。 CMX157是更多的比在体外相对于反对了到目前的治疗方法，这可能会反对的替诺福韦-耐药性的病毒（例如，K65R），，并对抗HBV的来与人允许了的活性具有耐药性的的所有的主要的艾滋病毒亚型的替诺福韦的的200-倍，更有力的。 CMX157的新颖的的结构结果，在下降了，循环作者：替诺福韦的各级，降低的全身暴露量，和从而减少了为肾功能的副作用的的潜力。 CMX157已完成第一阶段的健康志愿者的临床试验，显示出良好的安全性，耐受性和药物分布情况。

关于Chimerix

由经验丰富的抗病毒药物的开发团队领导，Chimerix与潜力，以提高生活质量，为患者在多种设置，包括器官移植，肿瘤，急性保健和全球卫生发展的新型口服抗病毒治疗。该公司专有的脂质技术已引起两个临床阶段化合物，CMX001和CMX157，这已经证明了目前批准的药物相比，活性增强，生物利用度和安全的潜力。

chimerix的铅化合物，CMX001，是一种广谱血脂无环核苷膦抑制双链DNA（dsDNA）的病毒，包括巨细胞病毒（CMV），腺病毒，BK病毒，单纯疱疹病毒和天花（天花）。 ，CMX001已完成二期临床发展为巨细胞病毒的预防，并在第2阶段的发展是抢占腺病毒感染的治疗和造血干细胞移植（HSCT）的受助人。到今天为止，已超过750名患者剂量与CMX001在对照临床试验和开放标签治疗方案。抗病毒活性的完成和正在进行的研究，再加上缺乏是目前可用的治疗相关的骨髓毒性和肾毒性，表明，CMX001具有的潜力，以提高干细胞和实体器官移植的成果。 chimerix已完成与FDA二期为CMX001的会议结束，正准备启动阶段3 CMX001临床的发展，在造血干细胞移植受助人巨细胞病毒的预防。

rocgao

抗病毒活性是提诺的200倍，有希望用于治疗替诺福韦耐药的hbv！绝对好消息！！期待

把握当下

替诺在hiv治疗药物中是啥地位？二线么？

sddp1

提诺也快黄花了。好消息

MP4

把握当下 发表于 2012-7-30 21:01
替诺在hiv治疗药物中是啥地位？二线么？

你竟然知道2线。
HIV是2线，有人当1线用，合并HBV是1线。
HBV是1线。

MP4

Phase 1 。。。。。。。。。。。。。。。。。。。。。。。。。。。。。。。。。。。。。。。。。。

咬牙硬挺

嗯，帮顶

rocgao

呵呵，好久没见到咬牙硬挺了

咬牙硬挺

to racgao:手机上网，前一阵子上不来啊，把我急坏了也